HomeIrelandKCI Manufacturing

KCI Manufacturing

Ireland · Athlone - Co. Westmeath Westmeath
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, South Korea — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 20 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 0 510(k), 0 PMA, 8 excluded
Brazil1 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: KCI Manufacturing · KCI MANUFACTURING

Company information

Country
Ireland
City
Athlone - Co. Westmeath Westmeath

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Negative Pressure Wound Therapy Powered Suction Pump 1Negative Pressure Wound Therapy Non-Powered Suction Apparatus 1Negative Pressure Wound Therapy Device For Reduction Of Wound Complications 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80624960014Curativo Customizável PrevenaClass I

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